- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266810
Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus (PROGRESS)
The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95815
- Sacramento Ear, Nose and Throat
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Torrance, California, United States, 90503
- Breathe Clear Institute of Sinus and Allergy Relief
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Connecticut
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Norwalk, Connecticut, United States, 06851
- The Connecticut Center for Advanced ENT Care
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District of Columbia
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Washington, District of Columbia, United States, 20006
- George Washington University Medical Faculty Associates
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Georgia
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Atlanta, Georgia, United States, 30342
- ENT of Georgia
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Kentucky
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Louisville, Kentucky, United States, 40207
- Advanced ENT and Allergy
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New York
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Albany, New York, United States, 12206
- Albany ENT and Allergy
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Texas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
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Virginia
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Norfolk, Virginia, United States, 23507
- East Virginia Medical School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient has CRS confirmed by CT scan and defined as symptoms lasting longer than 12 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.
- Patient has a clinical indication for and has consented to ESS including bilateral frontal sinus surgery.
- Chronic sinusitis diagnosis confirmed and documented by CT scan within 6 months of the procedure.
- Patient has bilateral disease in both frontal sinuses confirmed by Lund-Mackay score of ≥1 on each side.
- Planned sinus surgery includes bilateral ethmoidectomy (if judged necessary) and frontal sinus enlargement using Draf II (A or B) dissection or balloon dilation, with minimum of 5-mm diameter opening created.
- Technique used for frontal sinus surgery is the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)
- Septoplasty for access to the ostio-meatal complex is permitted.
- ESS including bilateral frontal sinus surgery has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement.
Exclusion Criteria:
- Known history of immune deficiency such as immunoglobin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV)
- Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma or other condition
- Known history of allergy or intolerance to corticosteroids or mometasone furoate
- Clinical evidence of acute bacterial sinusitis
- Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
- Active viral illness
- Concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease
- Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day follow-up period
- Currently participating in another clinical trial
- History of insulin dependent diabetes mellitus
- Patient has previously undergone ESS and experienced a CSF leak or has compromised vision as a result of a complication in a prior ESS procedure
- Significant complication during the current frontal sinus surgery procedure such as excessive blood loss, CSF leak or punctured lamina papyracea
- Current ESS including frontal sinus surgery is aborted for any reason.
- At least one side is not amenable for implant placement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PROPEL Mini Sinus Implant
Propel Mini placed in frontal sinus opening following ESS
|
Placement of sinus implant following frontal sinus surgery
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Active Comparator: Sinus Surgery alone: cohort 1
Sinus Surgery only: cohort 1: ESS with standard post-operative care.
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Sinus surgery only, without implant placement
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Experimental: PROPEL Nova Sinus Implant
Propel Nova placed in frontal sinus opening following ESS
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Placement of sinus implant following frontal sinus surgery
Other Names:
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Active Comparator: Sinus Surgery alone: cohort 2
Sinus Surgery only: cohort 2: ESS with standard post-operative care.
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Sinus surgery only, without implant placement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
Time Frame: Day 30
|
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). |
Day 30
|
Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
Time Frame: Day 30
|
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). |
Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Need for Post-operative Interventions (Propel Mini Cohort)
Time Frame: Day 30
|
Need for post-operative interventions by clinical investigators at Day 30 Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). |
Day 30
|
Need for Surgical Interventions (Propel Mini Cohort)
Time Frame: Day 30
|
Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO
|
Day 30
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Inflammation (Propel Mini Cohort)
Time Frame: Day 30
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The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.
|
Day 30
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Occlusion/Restenosis (Propel Mini Cohort)
Time Frame: Day 30
|
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent
|
Day 30
|
Need for Post-operative Interventions (Propel Nova Cohort)
Time Frame: Day 30
|
Need for post-operative interventions by clinical investigators at Day 30. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). |
Day 30
|
Need for Surgical Interventions (Propel Nova Cohort)
Time Frame: Day 30
|
Need for Surgical Interventions by clinical investigators at Day 30 Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO
|
Day 30
|
Inflammation (Propel Nova Cohort)
Time Frame: Day 30
|
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.
|
Day 30
|
Occlusion/Restenosis (Propel Nova Cohort)
Time Frame: Day 30
|
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent
|
Day 30
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy L. Smith, MD, MPH, Oregon Health and Science University
- Principal Investigator: Amber U. Luong, MD, PhD, The University of Texas Health Science Center, Houston
Publications and helpful links
General Publications
- Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1. Erratum In: Laryngoscope. 2020 Mar;130(3):836.
- Luong A, Ow RA, Singh A, Weiss RL, Han JK, Gerencer R, Stolovitzky JP, Stambaugh JW, Raman A. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jan;144(1):28-35. doi: 10.1001/jamaoto.2017.1859. Epub 2017 Nov 2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P500-0514
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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